TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework-Reference-Cited by-同舟云学术

TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework

Published:2016-07 Issue:4 Volume:50 Page:397-413
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Meeker-O’Connell Ann,Sam Leslie M.,Bergamo Nanci,Little Janis A.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479016651300.pdf

Reference12 articles.

1. Meeker-O’Connell A, Borda MM, Little JA, Sam LM. Enhancing quality and efficiency in clinical development through a clinical QMS conceptual framework: concept paper vision and outline. Therapeutic Innovation & Regulatory Science. 2015;49:615–622.

2. International Conference on Harmonisation (ICH). ICH Harmonised Tripartite Guideline: Pharmaceutical Quality System Q10 (Current Step 4 version). June 4, 2008.

3. International Organization for Standardization. ISO 9001:2008, Quality Management Systems. November 15, 2008.

4. International Organization for Standardization. ISO 9001:2015, Quality Management Systems. September 15, 2015.

5. Clinical Trials Transformation Initiative (CTTI). QbD (Quality by Design) Toolkit. Available at http://www.ctti-clinicaltrials.org/qbd. Accessed February 23, 2016.

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